The Problem of Colorectal Anastomosis Safety (ANSCRS)
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|ClinicalTrials.gov Identifier: NCT03958500|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Carcinoma Colorectal Neoplasms Colorectal Adenocarcinoma||Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Comprehensive anastomotic testing
All patients undergo:
Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally
The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
- Rate of anastomotic leakage [ Time Frame: 0 to 60 days ]The number of patients, who had clinical or radiological anastomotic leakage. Proctography will be performed 6-8 days and 4-6 weeks after the primary operation.
- Quality of life before and after the operation [ Time Frame: 0 to 60 days ]Using low anterior resection syndrome score (the LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).
- Quality of life before and after the operation [ Time Frame: 0 to 60 days ]
Using QLQ-C30 questionnaire. To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) before operation and 4-6 weeks after the operation.
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
- Reoperation rate [ Time Frame: 0 to 60 days ]Patients, who needed re-interventions
- Intraoperative test leakage [ Time Frame: 0 to 600 minutes ]Leakage rate detected intraoperatively after anastomosis testing
- Time of anastomosis testing [ Time Frame: 0 to 600 minutes ]Time from the start of the anastomosis testing till the end
- Operation time [ Time Frame: 0 to 600 minutes ]Time from the start of the operation until the end of the operation
- 90 days mortality [ Time Frame: 0 to 90 days ]the mortality of the patients after the operation
- Timing of anastomosis leakage [ Time Frame: 0 to 60 days ]In days after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958500
|Contact: Marius Kyzauskasfirstname.lastname@example.org|
|Contact: Tomas Poskus, email@example.com|
|National Cancer Institute, Vilnius, Lithuania||Recruiting|
|Contact: Audrius Dulskas, PhD. +37067520094 firstname.lastname@example.org|
|Vilnius University hospital Santaros klinikos||Recruiting|
|Contact: Tomas Poskus +37068678893 email@example.com|
|Principal Investigator:||Eligijus Poskus, prof.||Vilnius University, Vilnius, Lithuania|